Identity
- Trade Name
- Philips EUDAMEDFDA UDI
- Generic Name
- Air-conduction hearing aid, canal FDA UDI
- Device Name
- HEARLINK 1730 ITC FDA UDI
- Model / Reference
- HI (ITE) EUDAMED276904 EUDAMEDFDA UDI
- Description
- HEARLINK 1730 ITC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714464159109 EUDAMEDFDA UDI
- Basic UDI-DI
- 57144640-HI-00079-S7 EUDAMED
- FDA Product Code
- LRB FDA UDI
- EMDN Code
- Y2145060202 HEARING AIDS IN-THE-CANAL (ITC) EUDAMED
- GMDN Term
- Air-conduction hearing aid, canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Philips by Sbo Hearing A/S — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57144640-HI-00079-S7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (2)
- EUDAMED 5717cd99-3b7a-4e23-9b30-b40e76b0c953 61 fields · synced Jul 29, 2026
- FDA UDI cc5a673b-60a6-4fc0-8619-ba46b6255d8c 34 fields · synced May 30, 2026